Clinical Research Coordinator 2

The Clinical Research Coordinator II (CRC II) is responsible for independently managing and coordinating complex clinical research studies. This role involves overseeing the full lifecycle of clinical trials, including participant recruitment, data collection, and regulatory compliance. The CRC II plays a key role in ensuring that clinical studies are conducted efficiently, ethically, and in accordance with regulatory guidelines. This mid-level position requires previous experience in clinical research and a high degree of autonomy in managing studies.

 

 

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Program Management

1.    Plan and organize the entire lifecycle of clinical trials, from study start-up to close-out. This includes creating detailed timelines to ensure the study stays on track.
2.    Prioritize tasks and managing time effectively to handle multiple research projects simultaneously. This includes balancing participant recruitment, data collection, regulatory submissions, and communication with sponsors.
3.    Screen, recruit, and enroll study participants according to the inclusion/exclusion criteria outlined in study protocols.
4.    Obtain informed consent from study participants and ensure their understanding of study procedures.
5.    Identify potential risks or obstacles that could impact the success of the research project.  

Job Quality

1.    Ensures data is accurately collected, documented, and entered in appropriate databases or electronic case report forms (eCRFs). Proper documentation and adherence to the study protocol ensure reliable study outcomes and regulatory compliance.
2.    Ensures study is conducted according to the established protocol without deviations.
3.    Prioritizes participant safety and well-being by closely monitoring participants for adverse events, ensuring proper informed consent is obtained, and addressing any concerns participants may have. 
4.    Manage all aspects of the trial efficiently, including participant recruitment, data collection, and follow-up appointments ensuring that deadlines are met without compromising quality.
5.    Act as a liaison between study participants, physicians, and study staff, addressing participant concerns and ensuring clear communication throughout the trial.
 

Collaboration and Partnership 
1.    The CRC II works closely with the Principal Investigator (PI) to ensure all aspects of the study adhere to the protocol. This includes discussing study progress, addressing challenges, and ensuring that the PI is kept informed of participant recruitment, data collection, and regulatory submissions
2.    Coordinates with nurses, physicians, and lab technicians to ensure study-related clinical procedures, such as blood draws, diagnostic tests, and participant assessments, are performed accurately and on schedule. 
3.    Acts as a primary contact for study participants, ensuring they are well-informed about the study, answering their questions, and addressing concerns. This includes obtaining informed consent, guiding participants through the study process, and scheduling follow-up visits.
4.    Manages relationships with study sponsors, investigators and associated staff to provide the highest level of customer service.
5.    Maintain regular communication with the research team to share updates on study progress, patient recruitment, and any issues encountered during the trial. This includes attending team meetings and contributing to problem-solving discussions.
6.    Mentors junior clinical research staff including CRC I and Clinical Research Assistants (CRAs).

• Experience: Five (5) years of hands-on experience in clinical research
• Education: Bachelor's degree in a related field (e.g., biology, healthcare, nursing)
• License and Certification: Certification as a Clinical Research Coordinator (CRC) from the Association of Clinical Research Professionals (ACRP) or Certified Clinical Research Professional (CCRP) from the Society of Clinical Research Associates (SoCRA) is preferred.
• Skills and Abilities: effective communication, business writing, planning and organization, Microsoft efficient, and attention to detail.